15 CompareDetails PhUSE 2011 Brighton The COMPARE ProcedureComparison of WORK.MYCM with SDSOLD.CM(Method=EXACT)Comparison Results for ObservationsObservation in WORK.MYCM not found in SDSOLD.CM: USUBJID=CMSEQ=49.Observation in WORK.MYCM not found in SDSOLD.CM: USUBJID=CMSEQ=17.Observation in WORK.MYCM not found in SDSOLD.CM: USUBJID=CMSEQ=18.Observation in WORK.MYCM not found in SDSOLD.CM: USUBJID=CMSEQ=8.Observation in WORK.MYCM not found in SDSOLD.CM: USUBJID=CMSEQ=16.CompareDetailsPhUSE 2011 Brighton

16 ODS TRACE ON Datasets listed don’t come out in the order in the reportODS Data set only generated when used in the reporteg if duplicate ID variables appear then CompareDifferences section will be droppedOutput Added:Name: CompareDatasetsLabel: DatasetsData Name: BatchOutputPath: Compare.CompareDatasetsPhUSE 2011 Brighton

17 Compare the Market... INDEXES FORMATS Works with BY statementHas no effect with ID statement – data set needs sort or NOTSORTED option appliedFORMATSUnlike SUMMARY/MEANS, formats applied don’t get used by COMPARE – the variables are output without the formattingPhUSE 2011 Brighton

18 OUT= optionsOUTBASEWrites observation to the output dataset for every obs in BASEOUTCOMPlikewise for every obs in COMP data setOUTDIFwrites observation with the differences between COMP and BASEOUTPERCENTlike OUTDIF but % differenceOUTALLequivalent of all the aboveOUTNOEQUALOnly writes the obs when there is a differencePhUSE 2011 Brighton

20 Flagging the changes - a case studyStudy report submitted to FDA, but required 120 day safety update as part of New Drug ApplicationChanges to data needed to be shown in the updateLive database – could not roll back changesDatabase required a data cut on both occasionseg, if an AE ended after the date of data cut-off, this needed amending to ongoingPhUSE 2011 Brighton

21 COMPARE to the rescue!Generate SDTM for each variation of data slice and data cutGenerate Supplementary domains if requiredApply relevant data cut (if required) to parent and supplementary domainsCompare each variation of generated SDTM data and create flags from the results of that comparisonAdd flags to the previously generated SUPP domain. If it didn’t exist then create one.PhUSE 2011 Brighton